Registration Dossier

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1999-05-03 to 1999-05-07
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was performed under GLP and according to the official OECD guideline No 405.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report date:
1999

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
4-phenylbutan-2-one
EC Number:
219-847-4
EC Name:
4-phenylbutan-2-one
Cas Number:
2550-26-7
Molecular formula:
C10H12O
IUPAC Name:
4-phenylbutan-2-one
Test material form:
other: liquid
Details on test material:
- Physical state: liquid
- Stability under test conditions: not reported
- Storage condition of test material: cool and dry

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Charles River, Deutschland GmbH, Kisslegg, Germany
- Age at study initiation: not reported
- Weight at study initiation: 2 to 2.7 kg
- Housing: PPO cages with perforated floors (floor area about 2600 cm2)
- Diet (e.g. ad libitum): pelleted complete rabbit diet Altromin 2123 from Altromin, Lage/Lippe, Germany ad libitum
- Water (e.g. ad libitum): domestic quality drinking water acidified to pH 2.5 with hydrochloric acid
- Acclimation period: not reported

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 55 ± 15
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 hours light, 12 hours dark

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The right eye remained untreated and served as control
Amount / concentration applied:
0.1 mL of test substance was placed in the left eye of the rabbits
Duration of treatment / exposure:
Test substance was instilled once; no washing was conducted but after 24 hours Fluorescein was installed and the treated eye was washed with 20 mL 0.9% sodium chloride solution
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
4
Details on study design:
REMOVAL OF TEST SUBSTANCE
- substance was not removed from the treated eye

SCORING SYSTEM:
see section "Any other information on materials and methods"

TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein
Fluorescein was installed after 24 hours, eyes were rinsed with 20 mL 0.9% sodium chloride solution and were examined using UV light

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: mean of ratings at 24, 48 and 72 hours
Score:
0
Max. score:
4
Remarks on result:
other: Mean of all four tested animals
Irritation parameter:
iris score
Basis:
mean
Time point:
other: mean of ratings at 24, 48 and 72 hours
Score:
0
Max. score:
2
Remarks on result:
other: Mean of all four tested animals
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: mean of ratings at 24, 48 and 72 hours
Score:
0.3
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
other: Mean of all four tested animals
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: mean of ratings at 24, 48 and 72 hours
Score:
0
Max. score:
4
Remarks on result:
other: Mean of all four tested animals
Irritant / corrosive response data:
Some light response to exposure of the eyes to the substance was observed in all animals at the early timepoints of observation at 1 hour and 24 hours after instillation. After 48 and 72 hours all animals were free of any signs of eye irritation.
Other effects:
No other effects were reported

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The substance is non-irritating to the rabbit eye and does not need classification.
Executive summary:

The potential for eye irritation was tested for 4-phenylbutan-2-one in a GLP study according to OECD guideline No. 405. Four healthy SPF albino rabbits (New Zealand White) weighing 2 to 2.7 kg were used in the study. The day before testing both eyes of the animals were examined before and after the instillation of Fluorescein to ensure there were no defects or irritation. The next day an aliquot of 0.1 mL of the neat substance was placed in the left eyes of the animals by gently pulling the lower lid away from the eyeball. The lids were then gently hold together for one second. The right eye remained untreated and served as control. The eyes were examined and the grade of ocular reaction was recorded 1 and 24 hours later. After a first reading at 24 hours Fluorescein was instilled and the treated eye was rinsed with 20 mL 0.9% sodium chloride solution. Then the eye was examined again using UV-light to detect possible corneal damage. Further gradings were done after 48 and 72 hours after treatment. All animals showed slight conjunctival effects at the examinations occurring 1 and 24 hours after treatment. All these effects were transient and no reactions in the treated eyes of all four animals were seen in the examinations occurring 48 and 72 hours after treatment. On the basis of these observations it was concluded that the substance is non-irritating to the rabbit eye.